The FDA has walked away from a 2010 rule that would have forced drug makers to disclose fabricated data to regulators.
As Bloomberg Law reported last week, the FDA has withdrawn the proposed rule, “Reporting Information Regarding Falsification of Data,” which would
require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. A sponsor would be required to report this information to the appropriate FDA center promptly, but no later than 45 calendar days after the sponsor becomes aware of the information. This proposal is necessary because ambiguity in the current reporting scheme has caused confusion among sponsors. The proposed rule is intended to help ensure the validity of data that the agency receives in support of applications and petitions for FDA product approvals and authorization of certain labeling claims and to protect research subjects.
Bloomberg quoted an FDA representative as saying that the proposal is
no longer needed given other existing requirements around the integrity of clinical trial data.
Charles Seife, a journalism professor at New York University who has studied the way the FDA handles misconduct and other departures from sound research practices, told us that although the move doesn’t come as a surprise — the proposal seemed stalled since its arrival — it’s disconcerting:
I’m baffled that the FDA is saying that the rule isn’t needed. The regulations FDA cites as a justification aren’t meant to give FDA notice of falsification of data, merely if an investigator is terminated or an IRB changes its approval status. In cases of falsification, neither of these conditions are necessarily met.
In my view, FDA has done a poor job of dealing with the consequences of falsification or other research misconduct by investigators. This announcement certainly isn’t a step in the right direction.
The agency’s bioresearch monitoring program does review the integrity of some of the clinical data it receives. Whether it does so thoroughly is another matter. As Bloomberg reports:
In 2017, the program conducted 965 inspections, more than 700 of which examined the work of individual scientists. The FDA took enforcement action on about 1 percent of those researchers, according to an FDA presentation. About three-quarters of those cases resulted in no enforcement action, and the remaining 26 percent settled any findings with the FDA in voluntarily agreements.
The FDA would have done well to look Eastward for guidance. As it was turfing this potential consumer protection, China was laying down a $1.3 billion fine against a vaccine maker that officials concluded had submitted falsified data for its experimental vaccine against rabies.
According to the in-Pharma Technologist, at least 14 employees at the company, Changchun Changsheng, may be facing criminal charges in the case. Last year, courts in China called for the death penalty in some such cases.
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Too much money to be made; we certainly wouldn’t want a tiny thing like data falsification to keep our pharma buddies from enjoying their next post-approval share price jump. Totally in line with the Trump administration’s corporations-first philosophy.
The FDA’s unfortunate position overlooks what data falsification does to elevate the risk-to-benefits ratio (R/B). Regardless of how “safe” a clinical intervention may be, the R/B is still elevated by the lack of scientifically demonstrable potential benefit. In effect, the test patient is harmed by denial of access to an alternative treatment (via a test trial based on valid basic research that demonstrated promise). This now appears to be a topical subject, thanks to RW, which emphasizes the practical importance of prompt correction of the literature.
What Bloomberg calls “individual researchers” is what FDA calls clinical investigators. Those are the physicians who perform a clinical study sponsored by a drug or device company. They typically do a study while simultaneously seeing regular patients as part of their practice. There are clear requirements about record keeping, following IRB approved protocols. If FDA shows up at the clinic for an inspection, all the paperwork better be in order to show all regs are being followed. The CI knows this and should have someone in their office responsible. The sponsoring company should also be monitoring. But if the FDA shows up one day and they can’t find one study document for one patient, that’s a violation. The CI has to agree to do better. It does not surprise me that 26% of CI inspections found violations. This is not equivalent to research misconduct or falsification.
The China Plan for regulating liars….. No objection…. Putting people’s lives at risk for money is no different than murder for hire. Both are killing for profit in one instance the killer knows the identity of the vic in the other he doesn’t. All the same from the money point of view and the vic point of view and the killer’s point of view deserves no consideration.
https://www.statnews.com/2017/06/23/china-death-penalty-research-fraud/